Legal & Regulatory > Romania > Expenditure Control & Cost Containment Policies in Romanian Pharma

Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359.

1. Please describe the main cost containment policies in place in your country and their fundamental principles

a. Pricing and impact of generic/biosimilar approval

The price of off-patent innovative medicines cannot exceed, as a rule:

• the level of the innovative reference price (computed according to a special 65% reference rule, depending on the patent expiry date and on the presence of generic alternatives on the market); or,
• as the case may be, the level of the innovative reference price (computed according to a special 80% reference rule, depending on the patent expiry date and on the presence of biosimilar alternatives on the market).

b. Clawback/Payback/Discounts/Rebates

As a rule, the marketing authorisation holders and their legal representatives should pay on a quarterly basis the clawback tax for the medicines traded on the Romanian market; certain medicines are exempted from the payment of the clawback tax.

The marketing authorisation holders should pay the payback tax for the medicines which are reimbursed in Romanian based on a cost volume agreement.

NHIH could conclude additional protocols with pharmaceutical companies concerning special discounts or rebates for medicines.

c. Existence of Price/Volume agreements in the frame of public tendering

N/A

d. Existence of price freezes and cuts

Price freezes

The Romanian legislation in force provides for the possibility of the Ministry of Health to freeze the prices of medicinal products.

By law, in the case of a price freeze, imposed on all medicines or only a category of medicines, the Ministry of Health carries out an analysis at least once a year to determine whether the macroeconomic conditions require maintaining the freeze.

Within 90 days from the beginning of this analysis, the Ministry of Health should announce price increases or decreases, if any.

Exceptionally, marketing authorisation holders can ask for a derogation from the price freeze, for specific reasons.

Price cuts

The Romanian legislation in force provides for the possibility of the Ministry of Health to reduce the prices of medicinal products.

The Ministry of Health could request the reduction of the CANAMED manufacturer price, e.g., if the Ministry of Health or NAMMD find out that the marketing authorisation holder could supply the medicines in Romania at a level below the CANAMED manufacturer price.

e. Post-launch monitoring of prescriptions/sales

Post-launch monitoring of prescriptions/sales is quite abundantly regulated by the Romanian legislation which expressly provides for reporting obligations for several relevant actors, as follows:

i. wholesale distributors/importers/manufacturers should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including distribution outside the territory of Romania, carried out with medicines for human use from their own portfolio having the price approved in the CANAMED;
Also, wholesale distributors/importers/manufacturers should report to NAMMD, at the end of each calendar month, the situation regarding commercial operations, including parallel import, respectively the distribution of medicines outside the territory of Romania, in other states from the European Economic Area, carried out with medicines for human use from their own portfolio;

ii. closed and open circuit pharmacies should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including the release on consignment, as the case may be, for medicines having the price approved in the CANAMED;

iii. hospitals and dialysis centers should report monthly to the health insurance houses, the consumption of medicines, for the purposes of the computation of the clawback/payback contribution;

iv. open-circuit pharmacies report the monthly consumption of medicines, under the terms of the framework contract that regulates the conditions for providing medical assistance within the social health insurance system, for the purposes of the computation of the clawback/payback contribution.

The reporting provided under items (iii) and (iv) above is also made electronically, by using the SIUI (a specially designed program/system).

f. Existence of Generic Substitution Policies

In Romania, there were several initiatives for setting the cases in which a generic substitution is possible.

i. At prescriber level

Medicinal products with or without personal contribution reimbursed in the national health insurance system should be prescribed by physicians who are in contractual relationship with the health insurance houses.

As a rule, the physicians should prescribe the medicinal products by mentioning the relevant international non-proprietary name (INN) on the prescription. However, in medically justified cases and in case of biological products, the physicians could also mention on the prescription the relevant trade name of the prescribed products.

ii. At retail level

The patients will acquire the reimbursed medicinal products by presenting the prescriptions to the suppliers of medicinal products (e.g., pharmacies) which are in contractual relationship with the health insurance houses.

Unless the physician recommends a certain brand (trade) name, the pharmacist’s recommendation regarding the trade names corresponding to the INN prescribed by the physician should be in the ascending order of the price, starting with the cheapest medicinal product with the respective non-proprietary name (INN).

2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc)?

The Romanian legislation does not expressly regulate other policies in place aiming at cost control via incentive programs.